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Urin-based Point-of-Care Testing for Direct Oral Anticoagulants in Stroke Patients

Germany200 participantsStarted 2023-01-01

Plain-language summary

The goal of this study is to test a urine-based point-of-care testing device for direct oral anticoagulants in patients with stroke. The main questions are: * Can the test identify patients with direct oral anticoagulant intake? * Is there a time benefit of urine-based point-of-care testing compared to standard blood-based coagulation assessment? * Is the device feasible in the setting of acute stroke care?

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patient age ≥18 years at the time of admission * Clinical diagnosis of ischemic or hemorrhagic stroke. * Treatmet at our certified stroke-unit, University Hospital Giessen. * Phase 1 only: Confirmed intake of a direct oral anticoagulant (DOAC) for at least 48 hours (test group) or no intake of a DOAC (control group for specificity determination) * Phase II only, anamnestic intake of DOAC or no information about OAC-intake. * Phase II only, presentation with 4.5 hours after onset. Exclusion Criteria (only Phase II): * Contraindications for intravenous thrombolysis other than intake of DOAC * large vessel occlusion with indication for immediate endovascular thrombectomy * chronic renal insufficiency with need for hemodialysis

What they're measuring

Time-benefit of urine-based POC-testing versus standard blood-based coagulation assessment

Timeframe: 24 hours

Trial details

NCT IDNCT06037200

SponsorUniversity of Giessen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

Contact for this trial

Stefan Gerner, MD

+49-641/985-45301 stefan.gerner@neuro.med.uni-giessen.de

View on ClinicalTrials.gov More Stroke trials